Five-Year Outcomes with PCI Guided by Fractional Flow Reserve

Panagiotis Xaplanteris; Stephane Fournier; Nico H J Pijls; William F Fearon; Emanuele Barbato; Pim A L Tonino; Thomas Engstrøm; Stefan Kääb; Jan-Henk Dambrink; Gilles Rioufol; Gabor G Toth; Zsolt Piroth; Nils Witt; Ole Fröbert; Petr Kala; Axel Linke; Nicola Jagic; Martin Mates; Kreton Mavromatis; Habib Samady; Anand Irimpen; Keith Oldroyd; Gianluca Campo; Martina Rothenbühler; Peter Jüni; Bernard De Bruyne; FAME 2 Investigators

doi:10.1056/nejmoa1803538

Five-Year Outcomes with PCI Guided by Fractional Flow Reserve

Panagiotis Xaplanteris, Stephane Fournier, Nico H J Pijls, William F Fearon, Emanuele Barbato, Pim A L Tonino, Thomas Engstrøm, Stefan Kääb, Jan-Henk Dambrink, Gilles Rioufol, Gabor G Toth, Zsolt Piroth, Nils Witt, Ole Fröbert, Petr Kala, Axel Linke, Nicola Jagic, Martin Mates, Kreton Mavromatis, Habib SamadyAnand Irimpen, Keith Oldroyd, Gianluca Campo, Martina Rothenbühler, Peter Jüni, Bernard De Bruyne, FAME 2 Investigators

Department of Clinical Medicine

263 Citations (Scopus)

Abstract

BACKGROUND We hypothesized that fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) would be superior to medical therapy as initial treatment in patients with stable coronary artery disease. METHODS Among 1220 patients with angiographically significant stenoses, those in whom at least one stenosis was hemodynamically significant (FFR, ≤0.80) were randomly assigned to FFR-guided PCI plus medical therapy or to medical therapy alone. Patients in whom all stenoses had an FFR of more than 0.80 received medical therapy and were entered into a registry. The primary end point was a composite of death, myocardial infarction, or urgent revascularization. RESULTS A total of 888 patients underwent randomization (447 patients in the PCI group and 441 in the medical-therapy group). At 5 years, the rate of the primary end point was lower in the PCI group than in the medical-therapy group (13.9% vs. 27.0%; hazard ratio, 0.46; 95% confidence interval [CI], 0.34 to 0.63; P<0.001). The difference was driven by urgent revascularizations, which occurred in 6.3% of the patients in the PCI group as compared with 21.1% of those in the medical-therapy group (hazard ratio, 0.27; 95% CI, 0.18 to 0.41). There were no significant differences between the PCI group and the medical-therapy group in the rates of death (5.1% and 5.2%, respectively; hazard ratio, 0.98; 95% CI, 0.55 to 1.75) or myocardial infarction (8.1% and 12.0%; hazard ratio, 0.66; 95% CI, 0.43 to 1.00). There was no significant difference in the rate of the primary end point between the PCI group and the registry cohort (13.9% and 15.7%, respectively; hazard ratio, 0.88; 95% CI, 0.55 to 1.39). Relief from angina was more pronounced after PCI than after medical therapy. CONCLUSIONS In patients with stable coronary artery disease, an initial FFR-guided PCI strategy was associated with a significantly lower rate of the primary composite end point of death, myocardial infarction, or urgent revascularization at 5 years than medical therapy alone. Patients without hemodynamically significant stenoses had a favorable long-term outcome with medical therapy alone. (Funded by St. Jude Medical and others; FAME 2 ClinicalTrials.gov number, NCT01132495.)

Original language	English
Journal	The New England Journal of Medicine
Volume	379
Issue number	3
Pages (from-to)	250-259
ISSN	0028-4793
DOIs	https://doi.org/10.1056/nejmoa1803538
Publication status	Published - 19 Jul 2018

Keywords

Aged
Angina Pectoris/therapy
Antihypertensive Agents/therapeutic use
Coronary Disease/drug therapy
Coronary Stenosis/drug therapy
Drug-Eluting Stents
Female
Follow-Up Studies
Fractional Flow Reserve, Myocardial
Humans
Kaplan-Meier Estimate
Male
Middle Aged
Myocardial Infarction/epidemiology
Percutaneous Coronary Intervention
Platelet Aggregation Inhibitors/therapeutic use
Retreatment/statistics & numerical data

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Xaplanteris, P., Fournier, S., Pijls, N. H. J., Fearon, W. F., Barbato, E., Tonino, P. A. L., Engstrøm, T., Kääb, S., Dambrink, J.-H., Rioufol, G., Toth, G. G., Piroth, Z., Witt, N., Fröbert, O., Kala, P., Linke, A., Jagic, N., Mates, M., Mavromatis, K., ... FAME 2 Investigators (2018). Five-Year Outcomes with PCI Guided by Fractional Flow Reserve. The New England Journal of Medicine, 379(3), 250-259. https://doi.org/10.1056/nejmoa1803538

Xaplanteris, P, Fournier, S, Pijls, NHJ, Fearon, WF, Barbato, E, Tonino, PAL, Engstrøm, T, Kääb, S, Dambrink, J-H, Rioufol, G, Toth, GG, Piroth, Z, Witt, N, Fröbert, O, Kala, P, Linke, A, Jagic, N, Mates, M, Mavromatis, K, Samady, H, Irimpen, A, Oldroyd, K, Campo, G, Rothenbühler, M, Jüni, P, De Bruyne, B & FAME 2 Investigators 2018, 'Five-Year Outcomes with PCI Guided by Fractional Flow Reserve', The New England Journal of Medicine, vol. 379, no. 3, pp. 250-259. https://doi.org/10.1056/nejmoa1803538

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abstract = "BACKGROUND We hypothesized that fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) would be superior to medical therapy as initial treatment in patients with stable coronary artery disease. METHODS Among 1220 patients with angiographically significant stenoses, those in whom at least one stenosis was hemodynamically significant (FFR, ≤0.80) were randomly assigned to FFR-guided PCI plus medical therapy or to medical therapy alone. Patients in whom all stenoses had an FFR of more than 0.80 received medical therapy and were entered into a registry. The primary end point was a composite of death, myocardial infarction, or urgent revascularization. RESULTS A total of 888 patients underwent randomization (447 patients in the PCI group and 441 in the medical-therapy group). At 5 years, the rate of the primary end point was lower in the PCI group than in the medical-therapy group (13.9% vs. 27.0%; hazard ratio, 0.46; 95% confidence interval [CI], 0.34 to 0.63; P<0.001). The difference was driven by urgent revascularizations, which occurred in 6.3% of the patients in the PCI group as compared with 21.1% of those in the medical-therapy group (hazard ratio, 0.27; 95% CI, 0.18 to 0.41). There were no significant differences between the PCI group and the medical-therapy group in the rates of death (5.1% and 5.2%, respectively; hazard ratio, 0.98; 95% CI, 0.55 to 1.75) or myocardial infarction (8.1% and 12.0%; hazard ratio, 0.66; 95% CI, 0.43 to 1.00). There was no significant difference in the rate of the primary end point between the PCI group and the registry cohort (13.9% and 15.7%, respectively; hazard ratio, 0.88; 95% CI, 0.55 to 1.39). Relief from angina was more pronounced after PCI than after medical therapy. CONCLUSIONS In patients with stable coronary artery disease, an initial FFR-guided PCI strategy was associated with a significantly lower rate of the primary composite end point of death, myocardial infarction, or urgent revascularization at 5 years than medical therapy alone. Patients without hemodynamically significant stenoses had a favorable long-term outcome with medical therapy alone. (Funded by St. Jude Medical and others; FAME 2 ClinicalTrials.gov number, NCT01132495.)",

keywords = "Aged, Angina Pectoris/therapy, Antihypertensive Agents/therapeutic use, Coronary Disease/drug therapy, Coronary Stenosis/drug therapy, Drug-Eluting Stents, Female, Follow-Up Studies, Fractional Flow Reserve, Myocardial, Humans, Kaplan-Meier Estimate, Male, Middle Aged, Myocardial Infarction/epidemiology, Percutaneous Coronary Intervention, Platelet Aggregation Inhibitors/therapeutic use, Retreatment/statistics & numerical data",

author = "Panagiotis Xaplanteris and Stephane Fournier and Pijls, {Nico H J} and Fearon, {William F} and Emanuele Barbato and Tonino, {Pim A L} and Thomas Engstr{\o}m and Stefan K{\"a}{\"a}b and Jan-Henk Dambrink and Gilles Rioufol and Toth, {Gabor G} and Zsolt Piroth and Nils Witt and Ole Fr{\"o}bert and Petr Kala and Axel Linke and Nicola Jagic and Martin Mates and Kreton Mavromatis and Habib Samady and Anand Irimpen and Keith Oldroyd and Gianluca Campo and Martina Rothenb{\"u}hler and Peter J{\"u}ni and {De Bruyne}, Bernard and {FAME 2 Investigators}",

year = "2018",

month = jul,

day = "19",

doi = "10.1056/nejmoa1803538",

language = "English",

volume = "379",

pages = "250--259",

journal = "The New England Journal of Medicine",

issn = "0028-4793",

publisher = "Massachusetts Medical Society",

number = "3",

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TY - JOUR

T1 - Five-Year Outcomes with PCI Guided by Fractional Flow Reserve

AU - Xaplanteris, Panagiotis

AU - Fournier, Stephane

AU - Pijls, Nico H J

AU - Fearon, William F

AU - Barbato, Emanuele

AU - Tonino, Pim A L

AU - Engstrøm, Thomas

AU - Kääb, Stefan

AU - Dambrink, Jan-Henk

AU - Rioufol, Gilles

AU - Toth, Gabor G

AU - Piroth, Zsolt

AU - Witt, Nils

AU - Fröbert, Ole

AU - Kala, Petr

AU - Linke, Axel

AU - Jagic, Nicola

AU - Mates, Martin

AU - Mavromatis, Kreton

AU - Samady, Habib

AU - Irimpen, Anand

AU - Oldroyd, Keith

AU - Campo, Gianluca

AU - Rothenbühler, Martina

AU - Jüni, Peter

AU - De Bruyne, Bernard

AU - FAME 2 Investigators

PY - 2018/7/19

Y1 - 2018/7/19

N2 - BACKGROUND We hypothesized that fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) would be superior to medical therapy as initial treatment in patients with stable coronary artery disease. METHODS Among 1220 patients with angiographically significant stenoses, those in whom at least one stenosis was hemodynamically significant (FFR, ≤0.80) were randomly assigned to FFR-guided PCI plus medical therapy or to medical therapy alone. Patients in whom all stenoses had an FFR of more than 0.80 received medical therapy and were entered into a registry. The primary end point was a composite of death, myocardial infarction, or urgent revascularization. RESULTS A total of 888 patients underwent randomization (447 patients in the PCI group and 441 in the medical-therapy group). At 5 years, the rate of the primary end point was lower in the PCI group than in the medical-therapy group (13.9% vs. 27.0%; hazard ratio, 0.46; 95% confidence interval [CI], 0.34 to 0.63; P<0.001). The difference was driven by urgent revascularizations, which occurred in 6.3% of the patients in the PCI group as compared with 21.1% of those in the medical-therapy group (hazard ratio, 0.27; 95% CI, 0.18 to 0.41). There were no significant differences between the PCI group and the medical-therapy group in the rates of death (5.1% and 5.2%, respectively; hazard ratio, 0.98; 95% CI, 0.55 to 1.75) or myocardial infarction (8.1% and 12.0%; hazard ratio, 0.66; 95% CI, 0.43 to 1.00). There was no significant difference in the rate of the primary end point between the PCI group and the registry cohort (13.9% and 15.7%, respectively; hazard ratio, 0.88; 95% CI, 0.55 to 1.39). Relief from angina was more pronounced after PCI than after medical therapy. CONCLUSIONS In patients with stable coronary artery disease, an initial FFR-guided PCI strategy was associated with a significantly lower rate of the primary composite end point of death, myocardial infarction, or urgent revascularization at 5 years than medical therapy alone. Patients without hemodynamically significant stenoses had a favorable long-term outcome with medical therapy alone. (Funded by St. Jude Medical and others; FAME 2 ClinicalTrials.gov number, NCT01132495.)

AB - BACKGROUND We hypothesized that fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) would be superior to medical therapy as initial treatment in patients with stable coronary artery disease. METHODS Among 1220 patients with angiographically significant stenoses, those in whom at least one stenosis was hemodynamically significant (FFR, ≤0.80) were randomly assigned to FFR-guided PCI plus medical therapy or to medical therapy alone. Patients in whom all stenoses had an FFR of more than 0.80 received medical therapy and were entered into a registry. The primary end point was a composite of death, myocardial infarction, or urgent revascularization. RESULTS A total of 888 patients underwent randomization (447 patients in the PCI group and 441 in the medical-therapy group). At 5 years, the rate of the primary end point was lower in the PCI group than in the medical-therapy group (13.9% vs. 27.0%; hazard ratio, 0.46; 95% confidence interval [CI], 0.34 to 0.63; P<0.001). The difference was driven by urgent revascularizations, which occurred in 6.3% of the patients in the PCI group as compared with 21.1% of those in the medical-therapy group (hazard ratio, 0.27; 95% CI, 0.18 to 0.41). There were no significant differences between the PCI group and the medical-therapy group in the rates of death (5.1% and 5.2%, respectively; hazard ratio, 0.98; 95% CI, 0.55 to 1.75) or myocardial infarction (8.1% and 12.0%; hazard ratio, 0.66; 95% CI, 0.43 to 1.00). There was no significant difference in the rate of the primary end point between the PCI group and the registry cohort (13.9% and 15.7%, respectively; hazard ratio, 0.88; 95% CI, 0.55 to 1.39). Relief from angina was more pronounced after PCI than after medical therapy. CONCLUSIONS In patients with stable coronary artery disease, an initial FFR-guided PCI strategy was associated with a significantly lower rate of the primary composite end point of death, myocardial infarction, or urgent revascularization at 5 years than medical therapy alone. Patients without hemodynamically significant stenoses had a favorable long-term outcome with medical therapy alone. (Funded by St. Jude Medical and others; FAME 2 ClinicalTrials.gov number, NCT01132495.)

KW - Aged

KW - Angina Pectoris/therapy

KW - Antihypertensive Agents/therapeutic use

KW - Coronary Disease/drug therapy

KW - Coronary Stenosis/drug therapy

KW - Drug-Eluting Stents

KW - Female

KW - Follow-Up Studies

KW - Fractional Flow Reserve, Myocardial

KW - Humans

KW - Kaplan-Meier Estimate

KW - Male

KW - Middle Aged

KW - Myocardial Infarction/epidemiology

KW - Percutaneous Coronary Intervention

KW - Platelet Aggregation Inhibitors/therapeutic use

KW - Retreatment/statistics & numerical data

U2 - 10.1056/nejmoa1803538

DO - 10.1056/nejmoa1803538

M3 - Journal article

C2 - 29785878

SN - 0028-4793

VL - 379

SP - 250

EP - 259

JO - The New England Journal of Medicine

JF - The New England Journal of Medicine

IS - 3

ER -

Five-Year Outcomes with PCI Guided by Fractional Flow Reserve

Abstract

Keywords

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